Inspiratory Capacity and HRCT Comparison of Nebulized Arformoterol (Brovana) vs. Dry-powder Inhaler Salmeterol (Serevent)
Sponsor study identifier
interventional
20
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The investigators plan to enroll about 20 subjects who are at least 40 years old and have Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the investigators are looking at how much and for how long the two drugs can open up the small airways in the lungs. This will be done with breathing tests on all subjects, and with high resolution CT scans on subjects who agree to this optional part of the study. Half of subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take Serevent the first two weeks and Brovana the second two weeks. All subjects will also take Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms. After a Screening Visit to determine eligibility, subjects will be randomly assigned to receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include questionnaires, review of health and medications, and breathing tests before and after taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans before and after taking the study drug at both test visits.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2011
Actual (reported)May 27, 2011
Actual (reported)June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Inspiratory capacity (absolute volume BTPS, L)
The inspiratory capacity (absolute volume BTPS, L) measured 3 times prior to treatment and 5-6 times after treatment will be contrasted between the two treatments (nebulized arformoterol and DPI salmeterol) using a mixed effects linear model. The model will include treatment order, albuterol response FEV1 in mL, time of day and whether the IC was from plethysmography and time of prior dose of study med (nominal 12 hours).
Week 4
Inspiratory capacity (absolute change, % change, %predicted change)
Week 4
Inspiratory capacity (%ref TLC)
Week 4
Brovana (nebulized arformoterol) treatment for 2 weeks
Serevent (Salmeterol dry powder inhaler) treatment for 2 weeks
Arformoterol tartrate 15 µg/2ml (Brovana) nebulized via PARI-LC Plus® nebulizer with a mouthpiece, connected to a PRONEB® Ultra compressor. The nebulization time is \~9 minutes
Salmeterol 50 mcg (Serevent) via Diskus dry powder inhaler
UCLA
Los Angeles, California, 90095, United States
First Submitted
May 23, 2011
First Posted
May 27, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Other breathing test outcomes
Week 4
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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